Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, MS, MRI, Brain MRI, T2-FLAIR, Magnetic resonance imaging, T1-weighted MRI, 3D MRI, ENRAGED FLAIR, MRI sequence, Lesion detection, Neuroimaging
Brief summary
This study will evaluate a new brain MRI technique called ENRAGED FLAIR in patients with multiple sclerosis. MRI is central in the diagnosis and follow-up of multiple sclerosis because it can show inflammatory lesions in the brain. A standard MS brain MRI examination usually includes T2-FLAIR images, which are used to detect and assess MS lesions, and T1-weighted images, which provide anatomical information and help with interpretation of lesion location. These image types are usually acquired as separate scans. ENRAGED FLAIR is designed to acquire both T2-FLAIR and T1-weighted images during the same MRI sequence. The purpose of this study is to compare ENRAGED FLAIR with standard clinical MRI in patients with multiple sclerosis. Adult patients with multiple sclerosis who are already scheduled for a clinical brain MRI may be asked to participate. Participants will undergo one additional MRI sequence during the same visit. No extra contrast agent will be given, and no extra visit is required. The additional scan is expected to increase the examination time by about 5 to 10 minutes. The study will assess whether ENRAGED FLAIR provides image quality and MS lesion visualization comparable to standard MRI. If successful, this technique may help shorten future MRI examinations for patients with multiple sclerosis while preserving clinically useful image information.
Detailed description
Multiple sclerosis (MS) is commonly monitored with brain MRI. T2-FLAIR imaging is central for detecting and following MS lesions, while T1-weighted imaging provides anatomical information that supports lesion localization and interpretation. In routine clinical MRI, these contrasts are usually acquired as separate sequences, which increases examination time. ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence. The method uses otherwise unused recovery time in a FLAIR acquisition to acquire T1-weighted data. This may improve scan efficiency while preserving the clinically important information from both contrasts. This study is a prospective intra-individual comparison in adult patients with MS undergoing clinically indicated brain MRI. Each participant will undergo standard clinical MRI sequences and one additional ENRAGED FLAIR acquisition during the same examination. No additional contrast agent or study visit is required. Images from ENRAGED FLAIR will be compared with standard clinical T2-FLAIR and T1-weighted images. The evaluation will focus on MS lesion visualization, diagnostic image quality, and whether the simultaneously acquired T1-weighted images provide sufficient anatomical information for interpretation. Because each participant undergoes both standard MRI and ENRAGED FLAIR, each participant serves as their own control. The study is intended to determine whether ENRAGED FLAIR can provide image quality comparable to standard MRI in MS while potentially enabling shorter future brain MRI protocols.
Interventions
DIAGNOSTIC_TESTENRAGED FLAIR MRI
ENRAGED FLAIR is a combined MRI acquisition designed to generate both 3D T2-FLAIR and T1-weighted brain images from a single sequence. The additional sequence is acquired during the same clinical MRI examination and does not involve extra contrast agent or an additional study visit.
Sponsors
Region Stockholm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Outcome assessors performing image review will be masked to the acquisition method when feasible. Images will be reviewed in randomized order. Participants and MRI staff will not be masked because the ENRAGED FLAIR acquisition is added to the clinical MRI examination.
Intervention model description
All participants undergo the same study procedure: standard clinical brain MRI and one additional ENRAGED FLAIR MRI acquisition during the same examination. Each participant serves as their own control for comparison between ENRAGED FLAIR and standard MRI.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients, 18 years of age or older * Diagnosis of multiple sclerosis * Scheduled for a clinical brain MRI examination including T2-FLAIR and T1-weighted imaging * Able to provide written informed consent
Exclusion criteria
* Age under 18 years * Severe claustrophobia or inability to tolerate the additional MRI acquisition time * Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI Acquisition Time | From start to completion of each MRI acquisition used for the scan-time comparison, assessed up to 1 day. | Acquisition time for ENRAGED FLAIR will be compared with the combined acquisition time of the corresponding standard clinical T2-FLAIR and T1-weighted MRI sequences in the same examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MS Lesion Volume Agreement | After image processing and analysis, up to 12 months after enrollment | MS lesion volumes derived from ENRAGED FLAIR images will be compared with lesion volumes derived from standard clinical T2-FLAIR images using automated or semi-automated lesion segmentation. |
| T2-FLAIR Relative Diagnostic Image Quality Score on a 5-Point Preference Scale | At image review after the MRI examination, up to 12 months after enrollment | Blinded neuroradiologists will compare ENRAGED FLAIR-derived T2-FLAIR images with standard clinical T2-FLAIR images for MS lesion assessment and routine clinical interpretation using a 5-point relative diagnostic image quality scale. Scores range from 1 to 5: 1 = standard clinical T2-FLAIR strongly preferred, 2 = standard clinical T2-FLAIR slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T2-FLAIR slightly preferred, and 5 = ENRAGED FLAIR-derived T2-FLAIR strongly preferred. Higher scores favor ENRAGED FLAIR. |
| T1-Weighted Relative Diagnostic Image Quality Score on a 5-Point Preference Scale | At image review after the MRI examination, up to 12 months after enrollment. | Blinded neuroradiologists will compare ENRAGED FLAIR-derived T1-weighted images with standard clinical T1-weighted images for anatomical interpretability and support of MS lesion localization using a 5-point relative diagnostic image quality scale. Scores range from 1 to 5: 1 = standard clinical T1-weighted image strongly preferred, 2 = standard clinical T1-weighted image slightly preferred, 3 = no preference/equivalent diagnostic quality, 4 = ENRAGED FLAIR-derived T1-weighted image slightly preferred, and 5 = ENRAGED FLAIR-derived T1-weighted image strongly preferred. Higher scores favor ENRAGED FLAIR. |
| Automatic Brain Segmentation Agreement | After image processing and analysis, up to 12 months after enrollment | Brain tissue segmentation results derived from ENRAGED FLAIR images will be compared with segmentation results derived from standard clinical MRI images using automated brain segmentation software. Agreement will be assessed for relevant volumetric outputs used in MS image analysis. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORKarl Henric Rydén, PhD
Karolinska University Hospital
Outcome results
None listed